Optimi Health Corp, a manufacturer of GMP-certified MDMA and psilocybin, has received its U.S. FDA Establishment Identifier (FEI) number—a key regulatory step for engaging in FDA filings and compliant supply into the United States.
Dried psilocybin mushrooms (left) and MDMA tablets (right).
According to the U.S. Food and Drug Administration’s Drug Establishments Current Registration Site (DECRS), “The publication is a list of currently registered establishments which manufacture, prepare, propagate, compound, or process drugs that are distributed in the U.S. or offered for import to the U.S.” Optimi is now publicly listed among these registered drug production facilities.
With this designation, Optimi is formally recognized within the U.S. FDA system for the manufacture of pharmaceutical-grade MDMA and psilocybin, including both active ingredients and finished drug products. Supported by its Health Canada Drug Establishment Licence (DEL), the Company is positioned to supply these substances to authorized parties through controlled, cross-border channels between Canada and the United States.
Optimi’s ability to participate in the highly regulated U.S. pharmaceutical supply chain is a critical step, as the country represents the largest potential market for psychedelic-assisted therapies.
This recognition comes as 25 U.S. states have considered psychedelic legislation through more than 74 bills, underscoring the growing need for compliant, scalable, and cost-effective manufacturing to support responsible access to substances like MDMA and psilocybin.
Key Highlights
FDA Establishment Identifier (FEI): Confirms Optimi’s status as an FDA-registered pharmaceutical manufacturer—required for listing drug products, filing applications, and supplying U.S. distributors directly from its Canada-based facility.
DUNS Registration: Enables Optimi to transact with U.S. government agencies, institutions, and pharmaceutical companies seeking access to GMP-certified psychedelic medicines.
Finished Dosage Form (FDF) Capabilities: The Company produces pharmaceutical-grade MDMA and psilocybin in both active pharmaceutical ingredient (API) form and as encapsulated, ready-to-administer drug products for clinical and research use.
ANDA Pathway: Allows Optimi to file Abbreviated New Drug Applications (ANDAs) to obtain FDA approval for generic MDMA and psilocybin formulations as manufacturer of record.
DEA and U.S. Agent Alignment: Establishes Optimi’s ability to apply for import and export permits under DEA oversight, with a U.S. agent in place to support full regulatory compliance under controlled substances law.
“Securing U.S. FDA registration for our facility reflects our team’s commitment to the highest standards in pharmaceutical drug production,” said Dane Stevens, CEO of Optimi. “Being recognized now—on both sides of the border—is a strong validation of the infrastructure and manufacturing capabilities we’ve built at Optimi.”
“Should MDMA or psilocybin be formally rescheduled, or approved through an FDA New Drug Application (NDA), we intend to pursue ANDAs to support the supply of these medicines for PTSD, depression, and related indications. This milestone brings us one step closer to our goal of delivering cost-effective, GMP psychedelics at scale.”
